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International SARS-CoV-2 Infection Observational Study (ICOS) [COVID-19]

  • Research type

    Research Study

  • Full title

    An International Observational Study of Outpatients with SARS-CoV-2 Infection

  • IRAS ID

    283676

  • Contact name

    Sarah Pett

  • Contact email

    s.pett@ucl.ac.uk

  • Sponsor organisation

    Regents of the University of Minnesota

  • Duration of Study in the UK

    1 years, 7 months, 22 days

  • Research summary

    This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 who have been assessed as not requiring hospitalization (outpatients). \nAdults who seek testing for SARS-CoV-2 will be screened following consent. Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. \nThe general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. \nSecondary outcomes include participant-reported health status and change in severity of shortness of breath, if participants develop this.\nAs the understanding of the natural history of COVID-19 improves based on this and other studies, inclusion criteria and the data collection plan, including the outcomes assessed in this protocol, may be modified.

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    20/HRA/2207

  • Date of REC Opinion

    7 May 2020

  • REC opinion

    Favourable Opinion